GMP Audits in Pharmaceutical and Biotechnology Industries

The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities.

Features

• An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits
• Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards
• Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment
• Covers a global regulatory landscape
• Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology

Dedication

Preface

Author Biography

Abbreviation

Chapter 1 - The Concept of Quality

Chapter 2 - GMP Audits

Chapter 3 - GMP Auditing in Various Areas

Chapter 4 - Auditing Pharmaceutical Quality Management System

Chapter 5 - Alternative Auditing Methods

Chapter 6 - Audit Question Examples